Raberprazole Sodium D/r
NDC Package 61919-225-90

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Raberprazole Sodium D/r is 1.1 Healing of Erosive or Ulcerative GERD in AdultsRabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). Marketed by Direct Rx, this product is identified by NDC 61919-225 and is authorized under FDA application ANDA202376.

Identification & Billing

NDC Package Code
61919-225-90
Package Description
90 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
61919-225
11-Digit Billing Format
61919022590
RxNorm Crosswalk
  • RxCUI: 854868 - RABEprazole sodium 20 MG Delayed Release Oral Tablet
  • RxCUI: 854868 - rabeprazole sodium 20 MG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Raberprazole Sodium D/r
Dosage Form
-
Usage Information
1.1 Healing of Erosive or Ulcerative GERD in AdultsRabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered.1.2 Maintenance of Healing of Erosive or Ulcerative GERD in AdultsRabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.1.3 Treatment of Symptomatic GERD in AdultsRabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.1.4 Healing of Duodenal Ulcers in AdultsRabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in AdultsRabeprazole sodium delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.2) and the full prescribing information for clarithromycin].1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in AdultsRabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.1.7 Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and OlderRabeprazole sodium delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.

Regulatory & Marketing

Labeler Name
Direct Rx
FDA Application #
ANDA202376
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-30-2017
End Marketing Date
12-31-2023
Listing Expiration
12-31-2023
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61919-225). Click a package code to view its specific billing and regulatory data.

61919-225-30
30 TABLET, DELAYED RELEASE in 1 BOTTLE
61919-225-60
60 TABLET, DELAYED RELEASE in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 61919-225-90 identifies a specific commercial package of 90 tablet, delayed release in 1 bottle of Raberprazole Sodium D/r, labeled by Direct Rx. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Direct Rx on October 30, 2017. The current certification is valid through December 31, 2023.

How is this Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61919022590. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
61919-225-90
11-Digit CMS (5-4-2)
61919-0225-90

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.